Novel Therapy for Glucose Intolerance in HIV Disease

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Hypothesis that chromium picolinate improved insulin-stimulated glucose uptake by increasing the insulin receptor-mediated tyrosine phosphorylation of insulin receptor substrate-1, resulting in increased association with phosphatidylinositol 3-kinase. There was a significant negative correlation between the fasting glucose levels and the insulin sensitivity.

Original Primary Outcome Measures

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Outcome Measures

Not Provided

Original Other Outcome Measures

Not Provided

Descriptive Information

Brief Title

Novel Therapy for Glucose Intolerance in HIV Disease

Official Title

Novel Therapy for Glucose Intolerance in HIV Disease

Brief Summary

This research is to investigate the nutritional supplement chromium picolinate. The investigators are testing to see how effective this supplement is in treating insulin resistance associated with HIV disease.

Specific Aim 1 will assess quantitative improvements in insulin-mediated glucose disposal in a placebo-controlled clinical trial of chromium supplementation with 1000mpg (19.2 pmol) of chromium as chromium picolinate, overa two-month course of therapy. The investigators have shown that the insulin resistance (i.e. the inability of insulin to stimulate glucose uptake into peripheral tissues like muscle) in patients with HIV disease is associated with a defect in the insulin-signaling pathway leading from the insulin receptor, through phosphatidylinositol 3-kinase(PI 3-K, Figure 5). A similar defect in intracellular signaling has also been reported in patients with type 2 diabetes mellitus ):15-171. The cellular mechanism of improved insulin sensitivity with chromium supplementation will be determined in Specific Aim 2.

Specific Aim 2 will assess the effect of chromium supplementation on the insulin-stimulated activity of insulin receptor substrate-I-associated phosphatidylinositol 3-kinase in biopsies of muscle and fat tissue. This aim will also test the hypothesis that these physiological effects of chromium are mediated by alterations in the activity of insulin signaling. Understanding this mechanism may facilitate the design of even more effective strategies for improving insulin sensitivity.

Study Type

Observational

Study Design

Observational Model: Case ControlTime Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Fat and muscle biopsy samples

Sampling Method

Probability Sample

Study Population

Anyone with a positive diagnosis of HIV disease.

Condition

Insulin Resistance

Intervention

Dietary Supplement: Chromium Picolinate

Subjects will be asked to take chromium picolinate; 2 tablets per day, 1000 mcg or a placebo for a total of 8 weeks.

hepatitis C infection (if patients have had prior therapy and are now stable with no evidence of active infection they will be included. This will depend upon documentation from primary care giver).

CD4 counts below 300

viral load greater than 35,000.

Exclusion criteria (13) and (14) are added because the protocol requires that subjects be on a stable anti-retroviral regime for 3 months prior to study and 2 months on study. These criteria will make it less likely that anti-retroviral therapies will be switched in this subject population who are doing well.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

No

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

United States

Removed Location Countries

Administrative Information

NCT Number

NCT02006914

Other Study ID Numbers

R21AT002499

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Marie Gelato, Stony Brook University

Study Sponsor

Stony Brook University

Collaborators

Not Provided

Investigators

Principal Investigator:

Marie C Gelato, MD, PhD

Stony Brook University School of Medicine Dept. Of Medicine/Endocrinology